Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Open-label, Prospective Exploratory Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204034
• Other study ID #: PML-DOC-1003
• Secondary ID: 2010-019864-36
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2010
• Last updated: June 29, 2012
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients with documented COPD based on the following criteria:

Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC < 0.70

• Male or female patients aged = 40 years

• Patients should be treated according to the 'Global initiative for chronic Obstructive Lung Disease' (GOLD) guidelines

• Patients who present

• Moderate COPD with an FEV1 between 50 and 80% of predicted GOLD 2)

• Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3)

• Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4)

• Patients will be maintained on stable respiratory medications for 6 weeks prior to screening

• Patients with a co-operative attitude and ability to be trained to correctly use the pMDI

• Written informed consent obtained

Exclusion Criteria:

• Pregnant or lactating females or females at risk of pregnancy

• Unstable patients who developed an exacerbation during the last 4 weeks

• Inability to carry out pulmonary function testing

• Diagnosis of asthma as defined by the current 'Global Initiative for Asthma' (GINA) guidelines

• Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study

• Patients with a QTc interval (Bazett's formula) at the screening visit electrocardiogram (ECG) test >450 msec

• Cancer or any other chronic disease with poor prognosis and /or affecting patient status

• History of alcohol or drug abuse

• Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients

• Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study

• Patients who received any investigational new drug within the last 4 weeks prior to the screening visit

• Patients treated with any non-permitted concomitant medication

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Inuvair
6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol

Locations

Country	Name	City	State
Belgium	University Hospital of Antwerp	Edegem (Antwerp)	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral airway resistance (from 4th bifurcation on) for the segmented airways		at baseline and after 6 months of treatment	No
Primary	Total airway volume for the segmented airways		at baseline and after 6 months of treatment	No
Primary	Peripheral airway volume (from the 4th bifurcation on) for the segmented airways		at baseline and after 6 months of treatment	No
Primary	Relative compliance for each lobe		at baseline and after 6 months of treatment	No
Primary	Density of the lung parenchyma given per predefined lung zone		at baseline and after 6 months of treatment	No
Primary	Total airway resistance for the segmented airways		at baseline and after 6 months of treatment	No
Secondary	BODE index	The BODE index is a multidimensional index of disease severity . The index uses following parameters: body mass index (BMI); degree of airflow obstruction (Forced Expiratory Volume in 1 second (FEV1): % of predicted); functional dyspnea (Modified Medical Reseach Council (MMRC) dyspnea scale); exercise capacity (6 minute walk distance (6MWD) - m)	at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)	No
Secondary	COPD assessment test	The COPD assessment measures the impact of COPD on a person's life.	at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8)	No
Secondary	Borg CR10 Scale	The Borg CR10 Scale measures the present dyspnea.	At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Adverse events as a measure of safety	During the study patients will record record each day taken medication and any possible comments on the daily diary cards. Further more, patients are contacted at least once a month (either by phone or at a visit in the hospital).	during the study patients will record record each day taken medication and any possible comments on the daily diary cards	Yes
Secondary	Forced expiratory volume in 1 second (FEV1)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Forced Vital Capacity (FVC)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Peak Expiratory Flow (PEF)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Maximum expiratory flow rate at 50% of vital capacity (MEF50)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Maximal expiratory flow rate at 25% of vital capacity (MEF25)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Vital capacity (VC)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Inspiratory vital capacity (IVC)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Functional residual capacity (FRC)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Total Lung Capacity (TLC)		At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Airway resistance (Raw)		At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No
Secondary	Specific airways conductance (SGaw)		At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8)	No